Medical Device Supplier Certification: the Rx-360 Approach

By MedTech Intelligence Staff
March 19, 2014


• Categories: 05-Quality/Regulatory, RC - Medical Device Audits, Certification & Verification

In 2009, following the heparin adulteration incident, which resulted in 81 deaths and 785 reports of serious injuries associated with the use of the drug, industry leaders founded Rx-360 to address concerns about the security of the supply chain. 

An investigation by FDA traced the incident back to a Chinese Heparin supplier, and found found serious deficiencies at the supplier’s facility. But FDA also stated that it didn’t have the funds nor bear the responsibility to inspect on a regular basis overseas manufacturers of active pharmaceutical ingredients such as heparin. 

That was the impetus for the birth of Rx-360 whose mission is to: “Protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain.” (see box for Rx-360 objectives). And now, this largely pharmaceutical supply chain focused organization is expanding into the device world. 

Matthew Anderson, Vice President for Quality & Business Excellence at Merz North America, formerly with Baxter, is part of a team that is taking the lead on Rx-360’s initiatives in the medical device area. The initiative is now growing past the exploratory mode, says Anderson. “We have tried to understand if there’s a real need and interest within the industry and if people are willing to put in the necessary sweat equity, and the answer is yes,” he explains. 

Anderson, among others, explored alternatives for such a structure for the device space to actively monitor their supply chain and keep abreast of changes in the device regulatory scene, and kept coming back to Rx-360, because “they have the infrastructure to plan this and leverage it the right way, expedite things and provide value back to those that are interested in participating.” 

Anderson’s intent is to immediately leverage the handful of working groups that are already functioning effectively on the pharma side – to provide a mechanism to do shared audits and share audit reports, and provide communications on changing regulations. Many of the lessons learned in the pharmaceutical supply chain security are relevant to the device world as some of Rx-360’s pharma members also function in the device space, and these companies really understand the importance of securing their supply chains, Anderson describes. 

The Device Working Group under Rx360 will also create a mechanism to collaborate and share best practices. “In the legal world we live in, there are so many concerns around Intellectual Property, and that’s not an easy thing to overcome. Rx-360 has experience of handling such issues and this can help build the device side,” says Anderson. So far, companies such as Medtronic and GE Healthcare are leading the effort, to create and push this initiative to the next level. 

According to Anderson, the top three objectives that such a working group would aim to achieve would be: 

1. Sharing best practices and lessons learned in the Supply Chain; 
2. Sharing audit findings and reports: “This is a very real need to drive consistency in approaching audits. A big difference between drug and device suppliers is that device suppliers have a much larger supplier base. The challenge is how do you set an audit with 5000 or 10,000 suppliers? There is an increasing appetite to share audits and in Rx-360, you have a program to do this. This will increase your chances of doing better in audits, as you learn from these, and follow best practices,” he explains. 
3. Sharing regulatory intelligence: “While people in the industry are aware of the regulations, they are either in reactive mode, or they don’t have the required resources to track these changes. Rx-360 (pharma side) does really well when there are changing regulations. A volunteer SWAT team tracks these regulations, summarizes theses and pushes out a synthesis to the industry in a very timely manner, so you understand what’s going to be in the GMPs. We are attempting to do this in the device side as well,” Anderson explains. 

How will the new group work with regulatory agencies? Supply Chain management has been a real challenge for FDA and tough to solve, so they are extremely supportive of the initiative, says Anderson.

  For more information about this iniative, write to Matt Anderson at Matthew.Anderson@Merz.com.